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Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #17770
Bonjour à tous, According to recent guidelines issued by the French ANSM (Agence Nationale de Sécurité du Médicament et des produits de Santé), it is permitted to import by mail a personal supply of medication provided it is accompanied by a prescription from the country of origin. Here is a link to the "Fiche Pratique" published by the ANSM (March 2016): ansm.sante.fr/var/ansm_site/storage/orig...56a18d619d8c839b.pdf (see also ansm.sante.fr/Mediatheque/Publications/F...emarches-Medicaments) Here is my English translation: Individual importation of medications Individuals may only import a medication in a quantity that is consistent with a personal therapeutic use for a duration that does not normally exceed three months or for a duration of treatment indicated by the prescription. No authorisation is necessary to import medicine into French territories for an individual who personally transports the medication. When an individual imports a medication other than by personal transportation (that is to say by express carrier or by mail), prior authorisation is not required subject to the following cases: * the medication has been authorised for sale in France (French "AMM") or has been registered (e.g. for certain homeopathic or traditional medicines) in a member state of the European Economic Area; OR * the medication is authorised in the country of origin (outside the EEA) and the individual presents to the customs service a prescription confirming that the medication is for a treatment prescribed by an established doctor in that country. On the other hand, and always in the case of express or postal delivery, an authorisation from the ANSM for the importation is still necessary if the medication does not have an AMM or a registration in a state of origin belonging to the EEA; OR the medication is not authorised in the country of origin; OR the medication is authorised in the country of origin but the individual cannot present a prescription from an established doctor in that country. Attention: these provisions do not apply to medications classed as narcotics... In short (my interpretation): If medications such as Sofosbuvir, Daclatasvir, and Ledipasvir are authorised medications in country X, then it is allowed to import these medications from country X by mail or express courier if the importation is accompanied by a prescription from an established doctor in country X. Acknowledgement: This information was first highlighted by our friends from the Collectif Hépatites Virales (CHV): collectif-hepatites-virales.com/index.ph...cite-et-en-tolerance Vive la France!! Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog. Started Sof+Dac from fixHepC 10-Nov-2015. NO sides. Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000. Week4: AST 47, ALT 58. VL < 15 (unquantifiable). Week12 (EOT): AST 30, ALT 26, VL UND Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND Ever grateful to Dr James. Relapsed somewhere after all that... Bummer! Jan 2018: VL 63 000 (still GT3). | |
Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #17771
| Do I understand correctly that France and Fixhepc just became brothers? As long as France wants to renegotiate HCV drug prices, what France just did is a great strategic move. In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”. HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic. By sharing this Youtube video you might save someone’s life! My TX: HEPCVIR-L[generic Harvoni]-India SVR52 achieved |
Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #17772
Yeah, this should add a lot to the negotiations More generally, it certainly looks like a big step forward from the previous situation in France: fixhepc.com/forum/questions-and-answers/...egulations.html#2926 Still, for anyone importing to France by mail or courier service it might be a good idea to ask the doctor/supplier to include a print-out of the ANSM advice along with the prescription, if only to keep Fedex and DHL, etc., on the straight and narrow. Here it is again: ansm.sante.fr/var/ansm_site/storage/orig...56a18d619d8c839b.pdf Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog. Started Sof+Dac from fixHepC 10-Nov-2015. NO sides. Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000. Week4: AST 47, ALT 58. VL < 15 (unquantifiable). Week12 (EOT): AST 30, ALT 26, VL UND Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND Ever grateful to Dr James. Relapsed somewhere after all that... Bummer! Jan 2018: VL 63 000 (still GT3). | |
Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #17844
FedEx and DHL have a fast learning curve. They will be become "proactive" in short order, I imagine, making sure that all documentation is in order for a successful delivery to the destination country (France) before sending the package on its way. That has been my experience in dealing with them as far as US shipments go. m This email address is being protected from spambots. You need JavaScript enabled to view it. forums.delphiforums.com/generichcvtx G 1a F-1 Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil 11/17/15 4 wk lab ALT 17 AST 16 <15 11/18/15 Started Harvoni 12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND 1/14/16 Fin. Tx 7/07/16 UND SVR 24 | |
Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #18185
a recent post from hepatoweb.com (19/06/2016) Mai 2016 – Hépatite C: les génériques indiens des AAD aussi efficaces que les princeps Patients français, allez à l’étranger pour vous faire soigner ! En France, les nouveaux AAD sont remboursés chez les adultes chroniquement infectés par le VHC à partir du stade "F2 sévère" et, quel que soit le stade de fibrose hépatique, chez les personnes co-infectées par le VIH , ainsi que celles présentant une cryoglobulinémie mixte ou un lymphome B associé au VHC. Interrogé par Medscape édition française, le secrétaire général de l'Association française pour l'étude du foie (AFEF), le Pr Victor de Lédinghen, s'est dit "ravi" des résultats présentés par le Dr Freeman. « Désormais, nous allons pouvoir dire à nos patients, n'ayant pas accès au traitement, qu'ils peuvent envisager un séjour thérapeutique à l'étranger ». Si la France ne permet pas d'importer des médicaments, elle autorise le transport de médicaments à usage personnel en provenance d'un pays étranger. Selon la douane française, « la quantité transportée correspond à la durée du traitement prescrit sur l'ordonnance ou, à défaut, à trois mois de traitement ». La loi étant en faveur du transport de médicament, « cela ouvre la porte au séjour thérapeutique », souligne le Pr De Lédinghen. « Il faudra toutefois veiller à bien choisir le pays de destination, en privilégiant les fabricants ayant pu obtenir la licence du princeps ». Read the full article (also in French): hepatoweb.com/espace_actualites.php Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog. Started Sof+Dac from fixHepC 10-Nov-2015. NO sides. Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000. Week4: AST 47, ALT 58. VL < 15 (unquantifiable). Week12 (EOT): AST 30, ALT 26, VL UND Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND Ever grateful to Dr James. Relapsed somewhere after all that... Bummer! Jan 2018: VL 63 000 (still GT3). | |
Legally Importing Generics to France - Official Guidelines 7 years 10 months ago #18198
Thanks Vororo. For those who can't read French here is a translation of the full article courtesy of Mr Google who is much better at it than me.
G3a since '78 - Dx '12 - F4 (2xHCC) 24wk Tx - PEG/Riba/Dac 2013 relapsed 24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed 16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof SVR7 - 22/06/17 UND SRV12 - 27/07/17 UND SVR24 - 26/10/17 UND | |